In search of affordable medicines for the poor

MoS AYUSH (independent charge) and health and family welfare Shripad Yesso Naik addressing the gathering at the signing ceremony of the landmark agreement with WHO for collaboration in traditional systems of Medicine, at WHO Headquarters, in Geneva on May 13

A high-level panel hosted by India as part of the BRICS group of countries discussed the issues of trade deals that inhibit access to medicines and also limit policy space for governments to legislate in public interest.

Minister of state for health and family welfare Shripad Naik called the proliferation of regional trade agreements “a reality” but added that these processes should move “within the ambit” of the World Trade Organisation (WTO).

“We believe that the regional processes must move in tandem with the rules, standards and multilateral trade liberalisation, within the ambit of the WTO, to maximise overall gains, for all countries,” Naik said at the event that was organised on the sidelines of the 69th World Health Assembly that kicked off in Geneva on May 23.

“This will also pave the way for an expanded access to affordable medicines across the globe,” he added.

This is the first time that India hosted an event on health as the president of the BRICS bloc for this year. The panel that was co-sponsored by the BRICS countries saw a full house with attendance from the health ministers and deputy health ministers from across the BRICS bloc and also from Chile, apart from the presence of World Health Organisation (WHO) director-general Margaret Chan and UNAIDS executive director Michel Sidibé.

“The regional trade agreements should give priority to public health services, in particular remove barriers to all stakeholders that may endanger medicine accessibility and promote policy coordination,” said Li Bin, chair of the National Health and Family Planning Commission in China.

Li and the Russian deputy minister of health Sergei Kraevoi called for a better coordination among the BRICS countries that have robust generics industries to both counter spiraling drug prices and ensure better access for its population.

Citing a report of the Global Commission on HIV and the Law published in 2012 by the UN, South African minister of health Aaron Motsoaledi said that the current laws are failing to promote access innovation that serve the medical needs of the poor.

“Human well-being is the only reason we are ever given when any company innovates any new pharmaceutical (product). No other reason has ever been offered, at least not in public. We are not insensitive to the financial well-being of pharmaceutical companies, we are just but more sensitive to human well-being,” Motsoaledi said.

Increasing patents for non-communicable diseases (NCDs) – the incidence of which has steeply risen in India in the past few years – and also for biologics, is a glaring reality that poses emerging challenges to governments. The flexibilities ensured under the WTO’s Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement “are less likely to solve the problem of affordability and accessibility for this”. The developing states will have to find alternate methods to access these medicines “so people in developing countries may live”, the South African minister added.

Plurilateral trade deals

The issues around access to medicine, vaccines, and diagnostics are multi-dimensional –including possibilities of delinking the current patent-based funding system from research and development (R&D) costs of pharmaceutical products, incentivising companies to work on “non-profitable” diseases like tuberculosis (TB), ensuring that innovative products reach the general population and particularly, the poorer sections, and debates around how much leeway a government has to set its own national patent laws.

Ironically, however, access for the poor aside, drugs are getting too expensive even for developed countries. In the US medicine prices have doubled in the last five years. However, governments, particularly of the US, EU, Switzerland and Japan – all major host countries for the big pharma, demand stronger protection that will worsen the situation, Médecins Sans Frontières (MSF) said.

“The way we are going many countries are going to go bankrupt. How many countries can treat their way out of cancer, diabetes [etc.]? These are very expensive diseases,” Chan told the gathering.

The UN secretary-general Ban Ki-moon has set up a High-Level Panel on Access to Medicines to whip up solutions balancing the rights of inventors, international human rights law, trade rules and public health in the context of health technologies.

There has been a renewed emphasis in recent decades on regional trade deals that bypass multilateral rules agreed-upon by countries, particularly through private arbitration mechanisms that could potentially be used to sue governments legislating laws that work against company interests.

The so-called Investor-State Dispute Settlement (ISDS) mechanisms have seen a runaway proliferation in recent times with many governments being sued for legislating in public interest. For instance, tobacco giant Philip Morris sued Australia and Uruguay for anti-smoking measures that the governments had adopted and pharmaceutical giant Eli Lilly sued Canada under the North America Free Trade Agreement after it was stripped-off its patent rights to two new drugs.

A European report called ‘Profiting from Injustice’ says that there were 450 such known investor-state cases by the end of 2011.

“Health ministers certainly have to be sensitive to making sure that ISDS provisions are controlled under new agreements,” said Frederick M Abbot, an American academic, calling such mechanisms “a major threat”.

The challenge is also that health ministers don’t find space on the negotiating table when these trade deals are brokered.

“If you are not around the table, I was told, you are on the menu,” Dr. Chan said on a lighter vein though effectively putting her point across.

The ongoing trip of the US president Barack Obama to Asia to push, among other things, the Trans Pacific Partnership (TPP) – 12-nation Pacific Rim trade deal – has made human rights experts, policy makers and academics edgy.

Prof. Abbot also pointed out the “problematic” aspects of compulsory licensing exemptions in the TPP and the lack of clarity on how the agreement would sit with commitments made under Doha Declaration.

“The TPP is the worst-ever trade agreement with respect to access to medicines,” Rohit Malpani of MSF said.

Pharmacy for the poor

India is known as the pharmacy of the developing countries for its robust generic industry that supplies drugs to parts of the world that would be unable to afford such treatments otherwise – more than 50 percent of its $10 billion annual generic medicine production is exported.

For instance, in Africa, it currently costs $2 billion per year for putting 15 million people on HIV treatment that works out to $80 per person per year which otherwise would have spiked up to $150 billion per year. “If we didn’t have India, thanks to you, we didn’t have generics, no way we could have accessed those 15 million people at those costs of $2 billion,” Sidibé said.

Even after the innovation of HIV medicines, it took governments eight years to get them to the African people due to strict patent laws. “We were just seeing people die in hospitals – no access, no hope,” till the Indian generics burst into African hospitals, he said.

Referring to the Indian Patent Act, Naik cited the example of the expensive anti-cancer drug, Sorafenib, for which India issued a compulsory licence because the patented invention was not available at a reasonable price.

“The Indian courts, including the highest court, upheld the decision of the Indian Patents Office,” he added.

MSF urged India to “reject” the pressures exerted by through trade negotiations by US drugs’ companies “that seek to undermine its role as the pharmacy to the developing world”. The Regional Economic Comprehensive Partnership agreement could also potentially negatively impact the accessibility of affordable medicines in all the 16 negotiating countries, including India and China, the humanitarian organisation said.

“BRICS countries can resist trade agreements that block use of TRIPS flexibilities. They can do that,” Sidibé said.

States have a core obligation to protect the fundamental human rights of their citizens and “nothing that is negotiated under a free trade agreement can prevent a government from taking the necessary measures to invoke and defend that core obligation,” Abbot said.

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